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Not yet recruiting NCT06591507

Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

No phase Interventional Liver Transplantation Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BCAA Nutritional Intervention, Muscle Rehabilitation Training, Standard Nutritional Therapy.
Who it may be relevant to
Registry conditions: Liver Transplantation, Sarcopenia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation: a Clinical Multicenter Study

Overview

Patients undergoing liver transplantation frequently experience a reduction in skeletal muscle mass, malnutrition, and decreased levels of physical activity. These complications can adversely affect early postoperative recovery and the therapeutic effect of the transplant. This clinical study aims to investigate the effects of nutritional supplementation and rehabilitation therapy on sarcopenia associated with liver transplantation in adults. The goal is to establish a comprehensive perioperative intervention strategy to reduce the incidence of postoperative sarcopenia and improve transplantation outcomes.

Interventions

  • Dietary supplement BCAA Nutritional Intervention
    Patients will receive BCAA nutritional supplements. The supplement is taken orally twice daily, with each sachet containing 10g of powder, of which 6g is BCAA, and the remainder consists of preservatives and fruit flavorings to enhance palatability. The morning dose is taken with breakfast, and the second dose is taken as a late evening snack after dinner. For critically ill patients, enteral nutrition is provided instead. During each follow-up visit, patients are required to retain and submit a
  • Behavioral Muscle Rehabilitation Training
    Phase 1: Resistance Training (During Hospital Stay, First Month) Phase 2: Resistance Training (Home-Based, From Hospital Discharge Until 3 Months Post-Surgery) Phase 3: Physical Activity Training (Post-Surgery, After 3 Months)
  • Dietary supplement Standard Nutritional Therapy
    Standard Nutritional Therapy

Primary outcome measures

  • 2-year overall survival [Time frame: From enrollment to the end of follow-up at 2 years]
Secondary outcome measures (1)
  • Muscle mass [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 70 years.
  • Patients with end-stage liver disease who meet the criteria for liver transplantation (for liver cancer cases, only recipients meeting specific standards are included).
  • Complete clinical information, including documented pre-transplant muscle status (e.g., preoperative CT scans and handgrip strength tests).
  • High compliance with treatment, fully capable of independent action or having at least one assistant.
  • No contraindications to the planned interventions.

Exclusion criteria

  • Presence of musculoskeletal disorders before transplantation, such as myositis, idiopathic muscle atrophy, or history of hip surgery within the past three months.
  • Coexisting severe cardiovascular or cerebrovascular diseases, infectious diseases, or epilepsy.
  • Liver transplantation due to autoimmune liver disease or drug-induced liver failure.
  • Re-transplantation, multi-organ transplantation, living donor liver transplantation, split liver transplantation, or pediatric liver transplantation.
  • ABO-incompatible liver transplantation.
  • Incomplete clinical information.
  • Difficulty in follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06591507 · CT2024-ZJU-RCT1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗